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Prediction of Postoperative Pain by Injection Pain of Propofol

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ClinicalTrials.gov Identifier: NCT03021447
Recruitment Status : Unknown
Verified January 2017 by Go Un Roh, Ajou University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : January 16, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Go Un Roh, Ajou University School of Medicine

Tracking Information
First Submitted Date January 12, 2017
First Posted Date January 16, 2017
Last Update Posted Date January 16, 2017
Study Start Date January 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2017)
postoperative pain intensity_1 [ Time Frame: 10 min after postanesthesia care unit admission ]
Postoperative pain will be evaluated with verbal numeric scale (0-10)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 13, 2017)
  • postoperative pain intensity_2 [ Time Frame: 20 min after postanesthesia care unit admission ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)
  • postoperative pain intensity_3 [ Time Frame: 30 min after postanesthesia care unit admission ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)
  • postoperative pain intensity_4 [ Time Frame: 4 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)
  • postoperative pain intensity_8 [ Time Frame: 8 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)
  • postoperative pain intensity_12 [ Time Frame: 12 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)
  • postoperative pain intensity_24 [ Time Frame: 24 hours after operation ]
    Postoperative pain will be evaluated with verbal numeric scale (0-10)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction of Postoperative Pain by Injection Pain of Propofol
Official Title Not Provided
Brief Summary

Postoperative pain is a significant postoperative problem and it could be persistent if proper management is not provided. However, each patient shows different intensity of pain and different sensitivity to analgesics even if they underwent same procedures. Therefore, it would be useful to find the way to predict the postoperative pain sensitivity.

Propofol, a popular anesthetic agent, induces pain during injection, which can not completely prevented by opioid or lidocaine in some patients. This is considered to be related to patient's pain sensitivity and it might be associated with postoperative pain sensitivity.

Therefore, the relation of propofol injection pain and postoperative pain intensity will be explored.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients scheduled for laparoscopic cholecystectomy will be included.
Condition Cholecystitis, Acute
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 13, 2017)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • America Society of Anesthesiologists class I-II
  • Laparoscopic cholecystectomy

Exclusion Criteria:

  • Pregnancy
  • Illiteracy
Sex/Gender
Sexes Eligible for Study: Female
Ages 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03021447
Other Study ID Numbers AJIRB-MED-OBS-16-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Go Un Roh, Ajou University School of Medicine
Study Sponsor Ajou University School of Medicine
Collaborators Not Provided
Investigators Not Provided
PRS Account Ajou University School of Medicine
Verification Date January 2017